PRF + Minocycline vs Arestin in Non-surgical Perio Therapy | NCT07437209

Studies
PRF + Minocycline vs Arestin in Non-surgical Perio Therapy

NCT07437209

Sponsor

Center for Advanced Rejuvenation and Esthetics

Status

Completed

Last Update Posted

May 28, 2026Actual

Enrollment

15Actual

Phase

Phase 4

Conditions

Non-surgical Periodontal Therapy

Interventions

Arestin
PRF + M

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2024Actual

Primary Completion Date

Dec 1, 2025Actual

Completion Date

Dec 30, 2025Actual

First Submitted Date

Feb 22, 2026

First Submission Date that Met QC Criteria

Feb 22, 2026

First Posted Date

Feb 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2026

Last Update Posted Date

May 28, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nathan Estrin, Periodontist, Center for Advanced Rejuvenation and EstheticsPrincipal Investigator

Lead Sponsor

Center for Advanced Rejuvenation and EstheticsNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. While non-surgical periodontal therapy (NSPT) remains the first choice of treatment, its capability to completely resolve inflammation and pocketing in moderate disease severity may be limited, supporting the use of adjunctive antimicrobial or biologic interventions. Platelet-rich fibrin (PRF) and locally administered antibiotics, including minocycline, have individually shown clinical advantages; nonetheless, evidence assessing their combined utility remains unexplored. This split-mouth randomized controlled clinical trial (RCT) aims to compare the clinical efficacy of PRF combined with minocycline versus minocycline microspheres hydrochloride (Arestin) as adjuncts to NSPT in patients with Stage II or III, Grade A or B periodontitis.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arestin Group	Active Comparator	Arestin placed interproximal sites after non-surgical therapy	Drug: Arestin
PRF + M Group	Active Comparator	PRF with Minocycline placed interproximal sites after non-surgical therapy	Biological: PRF + M

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arestin	Drug	Arestin evaluated as an adjunct to non-surgical therapy	Arestin Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Attachment Loss	Clinical Attachment Loss was measured utilizing a periodontal probe at six sites per tooth.	6 months
Probing Depths	Probing depths were recorded utilizing a periodontal probe at six sites per tooth.	6 months
Gingival Recession	Gingival Recession was measured utilizing a periodontal probe at six sites per tooth.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and Female subjects requiring non-surgical periodontal therapy• No contraindications to periodontal treatment

Exclusion Criteria:

previous periodontal treatment within the past 6 months;
local or systemic antibiotic treatment within the past 3 months;
diagnosis of Stage I/ or IV periodontitis;
poor oral hygiene defined as a full-mouth plaque score >30%;
history of radiation or immunosuppressive therapy;
presence of neurologic disorders, major mechanical obstruction to mouth opening, or acute temporomandibular capsulitis;
systemic conditions that may compromise bone metabolism or wound healing such as metabolic bone disease, uncontrolled diabetes;
history of substance abuse such as drug or alcohol; or
current pregnancy, nursing, or planning pregnancy during the study period.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lakewood Ranch Dental		Sarasota	Florida	34240	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared upon request

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Beginning 3 months and ending 3 years after the publication of the results

Access Criteria

Data will be provided to researchers conducting a meta-analysis

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 21, 2026	Feb 22, 2026	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Feb 21, 2026	Feb 22, 2026	SAP_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
C562573	cyclopia sequence

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008911	Minocycline
D056690	Prolactin-Releasing Hormone

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

This will be a split-mouth study in which patients undergoing non-surgical periodontal therapy will be included. One interproximal site will be assigned to receive adjunctive Arestin while another site will be randomly assigned to receive platelet-rich Fibrin mixed with minocycline.